Device for examining dysfunction of the bladder

ABSTRACT

Apparatus for providing data for facilitating diagnosis of impairments to bladder function in humans by measurement of parameters associated therewith, includes device(s) for measuring at least one somatic function, such as pulse, blood pressure, galvanic skin resistance, core body temperature, and skin temperature. Certain embodiments of the apparatus also include device(s) for measuring non-somatic functions, such as bladder pressure, rectal pressure, urethral pressure, anal sphincter pressure, incontinenance event occurrence, and incontinence event severity. Other embodiments further include devices for measuring one or more of a patient&#39;s body position, body movements, body angle, cough reflex response, and bladder fullness. Still other embodiments further include devices for recording and storing measured data; a video device for observing a patient while sleeping; and electronic data transmitting and receiving devices for remote data transfer. In one embodiment, sensors for all measuring devices are located on a patient-wearable module.

The present invention relates to apparatus for investigatingpathological impairments to bladder functions.

Impairments to bladder functions due to damage to the central nervoussystem are the most common cause of urinary incontinence. Untreated,they always lead to a massive decline in quality of life and tosubstantially reduced life expectancy, especially after lesion of thespinal cord with paraplegia or other accident-related damage to thecentral nervous system, e.g., cranio-cerebral trauma. Thirty years ago,the survival time for quadriplegia, that is, paralysis of arms and legs,was a few months; for paraplegia, that is, paralysis of the legs only,it was a few years. At that time therapeutic measures in the urologicalfield comprised placement of a permanent catheter or care with diapersor a urinal, as well as surgical measures, possibly in terms ofperforming a sphincterotomy or installation of an artificial urine drainby circumventing the bladder by means of a section of intestine, e.g.,ileal conduit. Intensive neurological efforts over the past 20 yearshave led to a substantial improvement in this situation. Thus, today itcan be assumed that a paraplegic has practically no reduction in lifeexpectancy provided he undergoes regular check-ups in specializedcenters. Even after quadriplegia, substantial improvements in terms oflife expectancy have been achieved in the urological field consistentwith the magnitude of the lesion.

Thus a number of conservative and surgical therapy techniques are knownwith which specific pathological findings can be successfully treated ina very targeted manner. It is necessary to diagnose the precisepathological findings in order to employ the correct, custom-designedtherapy. However, in problematic cases this is not possible with therequired certainty, so that frequently an incorrect or inadequatetherapy is employed.

In standard urodynamics, the bladder is filled with a liquid using acatheter. A fill speed of 20 to 50 mL/min is provided, so that thefilling process takes approximately five minutes, which is approximately50 to 100 times faster than the bladder fills with urine naturally.While the bladder is undergoing artificial filling, the pressure insidethe bladder and the pressure inside the rectum are measured using twopressure sensors attached to catheters. A contraction in the bladdermusculature results in a positive difference between bladder pressureand rectum pressure. If this contraction occurs involuntarily while thebladder is being filled, this is an indication of a pathological changein bladder control. Rectum pressure is a reference value for bladderpressure. Because when there is coughing or when the abdominalmusculature is tensed, the interior pressure in the lower body increasesoverall, so that one measurement of bladder pressure alone is notadequate for detecting an involuntary contraction of the bladdermusculature. In addition, in standard urodynamics, liquid volume duringurination is frequently measured by means of a receptacle. In order toincrease accuracy, this measurement process is repeated one or twotimes, so that the measurement can last a total of 45 to 60 minutes. Themeasurement can even take up to two hours for neurogenic patients.

The disadvantage of standard urodynamics is the diagnosis' highsusceptibility to error. Thus, when the patient moves or changesposition, positive differences between bladder pressure and rectumpressure occur that have not been caused by involuntary contractions. Inaddition, the unnaturally rapid filling of the bladder provokesinvoluntary contractions in the bladder musculature, even in healthypatients. Therefore it does not provide an evaluation with reliablecertitude. This susceptibility to error is frequently a substantiallimitation in the diagnostic reliability of urodynamic investigations,especially in neurogenic patients.

Furthermore, in neurogenic patients with autonomic dysreflexia (highblood pressure, caused e.g. by movements or certain conditions ofvarious organs such as stomach, intestinal tract, and urinary tract, dueto insufficiency in blood pressure regulation using the nervus vagus),this autonomic dysreflexia is easily provoked by rapid bladder fillingand/or the bladder contraction caused thereby.

In video urodynamics, in addition to standard urodynamics the patient issubjected to x-ray examination approximately 8 to 10 times during themeasurement process. This is intended to make it possible to diagnosebladder/sphincter dyssynergia. Such dyssynergia is characterized in thatthe bladder musculature contracts although the sphincter musculature hasnot released the urethra. One possible consequence is that the urinebacks up to the kidneys, which can suffer damage as a result.

It is therefore one object of the present invention to eliminate theaforesaid disadvantages of known apparatus for investigatingpathological impairments to bladder functions. In particular knownapparatus are to be further developed such that evaluation certitude,i.e., diagnostic certitude, is substantially increased.

This object is attained by an apparatus in accordance with claim 1. Thedependent claims concern advantageous embodiments.

The present invention is based on the recognition that the investigationof somatic functions can be used to diagnose pathological impairments tobladder functions. It is therefore inventively suggested to provide oneor a plurality of means for measuring one or a plurality of somaticfunctions. These functions are in particular pulse, blood pressure, skinresistance, body core temperature and/or skin temperature of the personbeing examined. It has been demonstrated that evaluating one or aplurality of these somatic functions can be adequate for being able todiagnose pathological impairments to bladder functions, since somaticfunctions have a direct correlation to bladder contraction. In addition,there is a correlation between somatic functions and bladder filling.

A bladder contraction is triggered by the somatic system. As theconsequence of such triggering, the sweat glands open so that shortlyprior to and during a bladder contraction the skin resistance dropsalmost to zero, similar to a short circuit. Since normally skinresistance—depending on the position of the measuring electrodes—is inthe range of several kiloohms, this effect can be measured with greatreliability.

Due to somatic control for triggering a bladder contraction, acontraction of the blood vessels occurs, as well, and as a result thereis an immediate increase in blood pressure, which can itself be measuredwith great reliability. The pulse or cardiac rate increases, as well, asan indirect result of the increase in blood pressure and due to thedirect somatic control. Then, body core temperature drops as a result ofthe increased pulse rate, since increased blood circulation effects anelevated cooling effect in the interior of the body.

With an inventive apparatus, measurement is performed during a naturalfilling of the bladder by the patient's kidneys, diuresis. This avoidsprovoking autonomic dysreflexia due to unnaturally rapid filling of thebladder.

In addition, in accordance with the present invention means formeasuring non-somatic functions can be provided, in particular formeasuring bladder pressure, rectum pressure, urethral pressure, and/oranal sphincter pressure. These measurements diagnose impairments tobladder functions as is commonly done in the conventional manner instandard urodynamics.

Finally, in accordance with the present invention additional means canbe provided for measuring non-somatic functions or parameters, inparticular for measuring the position of the patient, his movementsduring the investigation, the angle of his legs or thighs relative tohis upper body, for measuring coughing, how full his bladder is, andtensing in the abdominal musculature and the musculature of the urethralsphincter muscle. All of these functions or parameters can be importantfor involuntary contractions of the bladder musculature.

The result is that the certitude of the evaluation increases if there isany uncertainty when the data from just somatic functions are evaluated.

The apparatus for providing data for facilitating diagnosis ofimpairments to bladder function in a human by enabling measurement ofparameters associated with bladder function, according to the presentinvention, generally includes at least one somatic function measuringmeans for measuring a somatic function of a human. The somatic functionmeasuring means is selected from the group consisting of: pulsemeasuring means; blood pressure measuring means; galvanic skinresistance measuring means; core body temperature measuring means; andskin temperature measuring means.

In the above apparatus, when the at least one somatic function measuringmeans is pulse measuring means, the pulse measuring means includes atleast one electrode cable and at least one pulse measuring clip selectedfrom the group consisting of ear-attachable pulse measuring clips;finger-attachable pulse measuring clips; and, where there is a pluralityof pulse measuring clips, combinations thereof.

In the foregoing apparatus, having blood pressure measuring means, it ispreferable that the blood pressure measuring means is non-invasive.

In the general apparatus of the present invention, when the at least onesomatic function measuring means is galvanic skin resistance measuringmeans, the galvanic skin resistance measuring means includes anelectrical voltage measuring apparatus that measures an electricalvoltage from an applied electrical voltage source at at least two siteson a skin surface; at least one electrode cable; and a plurality ofelectrodes.

In the foregoing apparatus, having core body temperature measuringmeans, the core body temperature measuring means is one of a rectallyinsertable temperature sensor for measuring core body temperature; andan orally ingestible temperature sensor for measuring core bodytemperature with an electronic signal transmitter for transmitting anelectronic signal representative of core body temperature measured bythe temperature sensor, to an external electronic signal receiver.

In the general apparatus of the present invention, when the at least onesomatic function measuring means is skin temperature measuring means,the skin temperature measuring means includes a skin surface contactingtemperature sensor.

The foregoing general apparatus of the present invention, including atleast one, and up to all of the aforesaid somatic function measuringmeans may further include at least one non-somatic function measuringmeans for measuring a non-somatic function of a human. The non-somaticfunction measuring means is selected from the group consisting of:bladder pressure measuring means; rectal pressure measuring means;urethral pressure measuring means; anal sphincter pressure measuringmeans; incontinenance event occurrence measuring means; and incontinenceevent severity measuring means.

In an embodiment of the general apparatus of the present invention thatalso includes non-somatic function measuring means, when the at leastone non-somatic function measuring means is bladder pressure measuringmeans, the bladder pressure measuring means includes a catheter having apressure sensor thereon for measuring bladder pressure.

In the foregoing apparatus, wherein the pressure sensor is on a distalend of the catheter, such that when the catheter is trans urethrallyinserted into a bladder, the sensor measures the bladder pressure. Thebladder pressure measuring means further includes an electronic signaltransmitter for transmitting an electronic signal representative of themeasured bladder pressure.

In the foregoing apparatus, the pressure sensor is at a proximal end ofthe catheter, on an external, non-urethrally insertable part thereof,and the bladder pressure measuring means further includes a pressuredetector/transmitter on a distal end of the catheter, such that when thecatheter is transurethrally inserted into a bladder, the pressuredetector/transmitter detects bladder pressure and transmits the bladderpressure through the catheter to the pressure sensor.

In an embodiment of the general apparatus of the present invention thatalso includes non-somatic function measuring means, when the at leastone non-somatic function measuring means is rectal pressure measuringmeans, the rectal pressure measuring means includes a catheter having apressure sensor thereon for measuring rectal pressure.

In the foregoing apparatus, the pressure sensor is on a distal end ofthe catheter, such that when the catheter is rectally inserted, thesensor measures the rectal pressure. The rectal pressure measuring meansfurther includes an electronic signal transmitter for transmitting anelectronic signal representative of the measured rectal pressure.

In the foregoing apparatus, the pressure sensor is at a proximal end ofthe catheter, on an external, non-rectally insertable part thereof, andthe rectal pressure measuring means further includes a pressuredetector/transmitter on a distal end of the catheter, such that when thecatheter is rectally inserted, the pressure detector/transmitter detectsrectal pressure and transmits the rectal pressure through the catheterto the pressure sensor.

In an embodiment of the general apparatus of the present invention thatalso includes non-somatic function measuring means, when the at leastone non-somatic function measuring means is urethral pressure measuringmeans, the urethral pressure measuring means includes a catheter havinga pressure sensor thereon for measuring urethral pressure.

In the foregoing apparatus, the pressure sensor is on a distal end ofthe catheter, such that when the catheter is urethrally inserted, thesensor measures the urethral pressure; and the urethral pressuremeasuring means further includes an electronic signal transmitter fortransmitting an electronic signal representative of the measuredurethral pressure.

In the foregoing apparatus, the pressure sensor is at a proximal end ofthe catheter, on an external, non-urethrally insertable part thereof,and the urethral pressure measuring means further includes a pressuredetector/transmitter on a distal end of the catheter, such that when thecatheter is urethrally inserted, the pressure detector/transmitterdetects urethral pressure and transmits the urethral pressure throughthe catheter to the pressure sensor.

In an embodiment of the general apparatus of the present invention thatalso includes non-somatic function measuring means, when the at leastone non-somatic function measuring means is anal sphincter pressuremeasuring means, the anal sphincter pressure measuring means includes acatheter having a pressure sensor thereon for measuring anal sphincterpressure.

In the foregoing apparatus, the pressure sensor is on a distal end ofthe catheter, such that when the catheter is rectally inserted up to ananal sphincter, the sensor measures the anal sphincter pressure. Theanal sphincter pressure measuring means further includes an electronicsignal transmitter for transmitting an electronic signal representativeof the measured anal sphincter pressure.

In the foregoing apparatus, the pressure sensor is at a proximal end ofthe catheter, on an external, non-rectally insertable part thereof, andthe anal sphincter pressure measuring means further includes a pressuredetector/transmitter on a distal end of the catheter, such that when thecatheter is rectally inserted up to an anal sphincter, the pressuredetector/transmitter detects anal sphincter pressure and transmits theanal sphincter pressure through the catheter to the pressure sensor.

One embodiment of the apparatus of the present invention includes bothbladder pressure measuring means and urethral pressure measuring means.Preferably, this embodiment has a single dual lumen catheter with atleast one pressure sensor thereon for measuring bladder pressure and formeasuring urethral pressure.

Another embodiment of the apparatus of the present invention includesrectal pressure measuring means and anal sphincter pressure measuringmeans. This embodiment has a single catheter with at least one pressuresensor thereon for measuring rectal pressure and for measuring analsphincter pressure.

In an embodiment of the general apparatus of the present invention thatalso includes non-somatic function measuring means, when the at leastone non-somatic function measuring means is incontinenance eventoccurrence measuring means, the incontinenance event occurrencemeasuring means includes a moisture sensor.

In the foregoing apparatus, the moisture sensor utilizes at least one ofresistance measurement and capacity measurement. The moisture sensor ispreferably integrated into a diaper.

In another embodiment of the general apparatus of the present inventionthat also includes non-somatic function measuring means, when the atleast one non-somatic function measuring means is incontinenance eventoccurrence measuring means, the incontinenance event occurrencemeasuring means includes a flowmeter that is alternatively externallyand internally patient-borne.

In the foregoing apparatus, the flowmeter is preferably on a catheter.

In an embodiment of the general apparatus of the present invention thatalso includes non-somatic function measuring means, when the at leastone non-somatic function measuring means is incontinenance eventseverity measuring means, the incontinenance event severity measuringmeans includes a diaper and a moisture sensor.

One embodiment of the apparatus of the present invention includesbladder pressure measuring means and incontinenance measuring means.Preferably, this embodiment has a single catheter having a pressuresensor thereon for measuring rectal pressure and for bearing a flowmeterfor measuring incontinenance.

A general embodiment of the apparatus of the present invention thatincludes at least one somatic function measuring means and additionallymay include at least one non-somatic function measuring means, mayfurther include body position measuring means for measuring a positionof a body of a patient.

In the foregoing apparatus, the body position measuring means includes ahollow outer sphere and an inner sphere, rotatably borne within thehollow outer sphere, the inner sphere having at least one of a surfacesegment thereof removed; and a center of gravity different from ageometric center of the inner sphere, such that the inner spheremaintains a constant angle relative to a gravitational direction.

In this embodiment of the apparatus, the inner sphere of the bodyposition measuring means has electrical contact surfaces on an externalsurface thereof, and the outer sphere of the body position measuringmeans has electrical contact surfaces on an internal surface thereof,such that a position of a body is determinable when the electricalcontact surfaces on the internal surface of the outer sphere are inelectrical contact with the electrical contact surfaces on the externalsurface of the inner sphere.

A general embodiment of the apparatus according to the present inventionthat includes any of the foregoing described measuring means may alsofurther include body movement measuring means for measuring movement ofa body of a patient.

In the foregoing apparatus, the body movement measuring means includes ashock sensor attachable to a body of a patient.

A general embodiment of the apparatus according to the present inventionthat includes any of the foregoing described measuring means may alsofurther include body angle measuring means for measuring a body anglebetween an upper body and a lower extremity, selected from the groupconsisting of: a thigh; and a leg, of the patient.

In the foregoing apparatus, the body angle measuring means includes atleast one light guide, longitudinally attachable to the lower extremityof the patient, for emitting light energy; a light source for providinglight energy to each of the at least one light guide; a light sensor,for detecting light energy emitted by each of the at least one lightguide, and for producing a signal representative thereof; andcalculation means for calculating the body angle from the signalproduced by the light sensor.

In the foregoing apparatus, each of the at least one light guidepreferably includes a fiber optic cable.

A general embodiment of the apparatus according to the present inventionthat includes any of the foregoing described measuring means may alsofurther include cough detection means for detecting and registering theoccurrence of a cough reflex in the patient.

In the foregoing apparatus, the cough detection means includes acousticdetection means for detecting acoustic signals.

According to one embodiment of the foregoing apparatus, the acousticdetection means is a microphone.

According to another embodiment of the foregoing apparatus, the coughdetection means includes a longitudinally elastically extensiblethoracic band for close contacting placement around a thorax of apatient; and a sensor for measuring a change in length of the thoracicband upon occurrence of a cough reflex in the patient.

An embodiment of the foregoing apparatus that includes acousticdetection means further includes a microprocessor for analyzing theacoustic signals detected by the acoustic detection means fordetermining the occurrence of a cough reflex in the patient.

A general embodiment of the apparatus according to the present inventionthat includes any of the foregoing described measuring means may alsofurther include muscle tension measuring means for measuring muscletension in at least one muscle selected from the group consisting of:abdominal musculature; and urethral sphincter muscle; the muscle tensionmeasuring means including a plurality of electrodes for measuringvoltage produced by the muscle.

A general embodiment of the apparatus according to the present inventionthat includes any of the foregoing described measuring means may alsofurther include bladder fullness measuring means for measuring a volumeof fluid in a bladder of a patient.

A general embodiment of the apparatus according to the present inventionthat includes any of the foregoing described measuring means may alsofurther include data recording and storing means for recording andstoring data obtained by any of the measuring means and the detectionmeans.

In the foregoing apparatus, the data recording and storing means storesdata for a predetermined period of time.

In the foregoing apparatus, the data recording and storing meansincludes at least one of: magnetic medium; optical medium; analogmedium; digital medium; and combinations thereof.

In the foregoing apparatus, when the recording and storing means is adigital medium, the digital medium includes a plurality of digitalintegrated circuit memory chips.

In any of the foregoing embodiments of the apparatus having recordingand storing means, the recording and storing means is preferablyerasable and rewriteable.

In any of the foregoing embodiments of the apparatus having recordingand storing means, the recording and storing means has sufficientcapacity to record and store data for at least two hours, preferably forlonger than two hours, more preferably for six hours, and mostpreferably for 24 hours.

A general embodiment of the apparatus according to the present inventionthat includes any of the foregoing described measuring means may alsofurther include marker means for enabling patient-actuated manual entryof data into the recording and storing means.

In the foregoing apparatus, the data to be manually entered is datarelating to occurrence of patient-subjectively-experienced eventsrelating to bladder function.

In the foregoing apparatus, the marker means is alternatively one or aplurality of user-actuated devices. The user-actuated devices areselected from the group consisting of: buttons, switches, knobs, and,where there is a plurality of the user-actuated devices, combinationsthereof.

In the foregoing apparatus, when there is one user-actuated device, thedevice is multifunctional and capable of separately marking occurrenceof a plurality of different events of a predetermined nature; and whenthere is a plurality of user-actuated devices, each of the devices isdedicated to marking single or repetitive occurrence of an event of apredetermined nature.

In the foregoing apparatus, the marker means is capable of determining arelative intensity of each occurrence of thepatient-subjectively-experienced event relating to bladder functiontriggering user actuation of the marker means.

The relative intensity of each the occurrence of thepatient-subjectively-experienced event relating to bladder function isexpressed through a characteristic parameter of the marker means.

According to one embodiment of the foregoing apparatus, the marker meansis a variable rheostat and characteristic parameter is electricalresistance.

According to certain embodiments of the foregoing apparatus, a parameterof an output signal of the marker means is proportional to a relativeintensity of the patient-subjectively-experienced event relating tobladder function.

In embodiments of the foregoing apparatus, when the marker meansincludes a button, relative intensity of thepatient-subjectively-experienced event relating to bladder function isexpressed by one of proportionality of a user-applied force to thebutton and frequency of repetitive actuation of the button; when themarker means includes a switch, relative intensity of thepatient-subjectively-experienced event relating to bladder function isexpressed by one of selection of a position of a more than bipositionalmultipositional switch and by frequency of repetitive actuation of theswitch; and when the marker means includes a rotatable knob, relativeintensity of the patient-subjectively-experienced event relating tobladder function is expressed by selection of a position of the knobcoordinated to indicia of intensity.

In any of the foregoing embodiments of the apparatus including markermeans, some of the patient-subjectively-experienced events relating tobladder function include, but are not limited to: consumption of liquidby the patient; sensation of an urge to urinate; and an actual urinationevent.

A general embodiment of the apparatus according to the present inventionthat includes any of the foregoing described measuring means may alsofurther include video image recording means for recording patient imagedata.

In the foregoing apparatus, the video image recording means can include,but is not limited to, one selected from the group consisting of a videocamera and a digital camera.

In the foregoing apparatus, one main function of the video imagerecording means is to record patient image data, while the patient issleeping, so as to determine occurrence of events symptomatic ofimpaired bladder function in the patient, such as movement andrestlessness, which may signify pain or discomfort, and/or to record thetime of occurrence of an actual event, related to bladder impairment,such as an incontinenance event, which occurs while the patient is in asomnolent state and may not recall or be able to precisely time theoccurrence of later when the patient is awake.

In the foregoing apparatus, when the video image recording means is adigital camera, the digital camera further includes digital storagemeans for storing digital image data recorded by the digital camera fora period of up to 12 hours. The digital storage means includes at leastone digital memory card.

A general embodiment of the apparatus according to the present inventionthat includes any of the foregoing described measuring means may alsofurther include a transmitter for transmitting data representative ofmeasured values obtained by at least some of the measuring means and thedetection means.

In the foregoing apparatus, preferably the transmitter is electronic andthe data is transmitted electronically.

A general embodiment of the apparatus according to the present inventionthat includes any of the foregoing described measuring means may alsofurther include a receiver for receiving data transmitted by thetransmitter.

In the foregoing apparatus, preferably the receiver is electronic andthe data is transmitted by the transmitter and received by the receiverelectronically.

In the foregoing apparatus, the data is electronically transmitted andreceived by one selected from the group consisting of: radio waves; andlight waves, but is not limited thereto.

According to certain embodiments of the foregoing apparatus, the data iselectronically transmitted and received by radio waves.

In certain embodiments of the foregoing apparatus, electronic datatransmission and reception is wireless.

In one preferred embodiment, thereof, the radio waves are short rangeradio waves. One example of such technology is that incorporating whatis known as Bluetooth® technology.

In certain embodiments of the foregoing apparatus, at least one ofelectronic data transmission by the transmitter; electronic datareception by the receiver; and electronic communication between thetransmitter and the receiver, occurs automatically.

In one embodiment of the foregoing apparatus, the data recording andstoring means and the receiver are proximally located.

In yet another general embodiment of the apparatus according to thepresent invention that includes any of the foregoing described measuringmeans and detection means, the data recording and storing means ishoused in a portable module. In certain embodiments thereof, theportable module is patient-wearable. Preferably, all of the measuringmeans and the detection means are in electronic communication with themodule. For convenience and mobility, the module is battery powered.

The present invention is explained in greater detail in the followingusing a preferred exemplary embodiment and the accompanying drawingfigures, wherein:

FIG. 1 illustrates a block diagram of a preferred embodiment of theinventive apparatus (“UroLog”), and

FIG. 2 illustrates one module in accordance with a preferred embodimentof the inventive apparatus (“UroLog”) with connectors and connectingcables.

In accordance with one preferred embodiment, the inventive apparatus forinvestigating impairments to bladder functions includes a compact modulethat during the investigation period is situated on or in the vicinityof the body of the person being examined. FIG. 1 illustrates this modulesymbolically. Connected to the module is means or a plurality of meansfor measuring various somatic and/or non-somatic functions or parametersof the person via serial interfaces or via signal preparation units. Ifnecessary, one or more other means for measuring other conditions canalso be connected to the module.

The data measured by these means are stored by means for recording datathat is arranged in the module and preferably includes 4 MBits or 8MBits of memory. However, a transmitter can also be arranged in or onthe module; it transmits the data to a stationary receiver. In thiscase, the means for recording data does not have to be in arranged inthe module, but can also be arranged stationary at the receiver, wherebythe receiver forwards the data to the recording means for recording.

As in conventional urodynamics, the apparatus illustrated in FIG. 1measures bladder pressure and rectal pressure. Pressure sensors can beemployed that are introduced into the patient's bladder or rectum via acatheter. A Wheatstone bridge can be used for the pressure sensors,whereby a resistance depends on pressure. The pressure sensors areconnected to the module via electrically conducting cable.

In the apparatus illustrated in FIG. 1, pulse rate, skin resistance, andskin temperature are measured for the somatic functions. When there is acontraction in the bladder musculature—depending on the position of themeasuring electrodes—the skin resistance drops from a few kiloohms toalmost zero, similar to a short circuit. Two or more electrodes can beused for this that can be arranged e.g. in the region of the hand. Asanother result of a contraction of the bladder musculature, bloodvessels constrict so that blood pressure also rises immediately. Bloodpressure can be measured preferably in a non-invasive manner.

The pulse rate also increases as a result of the increase in bloodpressure and due to direct somatic triggering. In the apparatusillustrated in FIG. 1, the pulse rate is preferably measured using anear clip. With such an ear clip, the earlobe is illuminated with a lightsource, whereby the quantity of light that passes through the earchanges periodically with the pulse beat. A light sensor measures thisperiodic change in light intensity. Alternatively, two electrodes thatare arranged in the region of the heart can also be employed to measurethe pulse. These electrodes can measure a voltage that is producedduring contraction of the cardiac musculature. In addition, it ispossible to measure the pulse using a finger clip, whereby oxygensaturation provides the initial value for the measurement.

Since somatic triggering opens the sweat glands during a contraction ofthe bladder musculature, there is elevated evaporation from the surfaceof the skin so that the skin temperature drops correspondingly. Thiseffect can be measured using temperature-sensitive resistances that canbe arranged on the skin surface, e.g. in the region of an arm.

A contraction of the bladder musculature or a positive differencebetween bladder pressure and rectum pressure can also result fromcorresponding movements by the patient, e.g. tensing of the abdominalmusculature, or from coughing. Therefore in accordance with onepreferred embodiment of the invention, a sensor for measuring tensing ofthe abdominal musculature, a motion sensor, and a sensor for determiningbody position are provided. Coughing, which is connected to suddentensing of the abdominal musculature, can be detected using amicrophone. Alternatively, however, a band can also be arranged aboutthe thorax, whereby coughing is detected via sudden shortening of thecircumference of the thorax.

In addition to being important for bladder filling, the patient'smovement, body position, and leg position during the investigationperiod is important for the urge to urinate and for involuntarycontractions of the bladder musculature. Leg position, in particular theangle between upper body and thigh, can be measured using a fiberglasscluster, whereby a light source is arranged at one end of the fiberglasscluster, and a light sensor is arranged at the other end. The fiberglasscluster is preferably attached laterally on the thorax and laterallyalong the thigh. When the patient is standing or lying flat, a maximumquantity of light travels through the fiberglass cluster. However, whenthe angle between upper body and thigh changes, the fiberglass clusteris bent somewhat so that less light travels all the way through thefiberglass cluster.

The inventive apparatus can furthermore include a video or digitalcameral and a memory card for collecting image data. Image data aboutmovements can be collected, especially while the patient is sleeping, inorder to attain certitude in the evaluation.

Finally, a moisture sensor that is arranged preferably in a diaper and aflow measuring device can measure the existence and severity of anyincontinence.

Marking buttons for manual actuation by the patient can also beprovided. This makes it possible for the patient to mark certain events,such as e.g. the sensation of a need to urinate. Corresponding inputscan later also be taken into account in the evaluation.

The module is preferably operated using a battery or an accumulator, inparticular two AAA batteries. This makes it possible for the person tobe evaluated to move freely, as he normally would, for the period of theinvestigation, which can take up to 30 hours, or, depending on scanningrate and memory, up to 20 days. The scanning rate can be selected freelystarting with scanning every two minutes up to a maximum 1024 Hz.

After the investigation period, the module can be connected via a serialinterface, in particular via an RS-232 port with interface, to acomputer with which the measured data can be evaluated using evaluationsoftware. Evaluation of the data can also be evaluated by a physicianusing a graphic representation, however, in order to arrive at thecorrect diagnosis.

FIG. 2 illustrates a module 1 in accordance with one preferredembodiment of the inventive apparatus (“UroLog”) with connectors andcables. The module 1 is 58 mm×105 mm×19 mm in size, weighs approximately0.2 kg, and is splash-resistant or—if necessary—water-tight. Attached tothe module is a connector 2 with cables, whereby at the ends of thecables are an “EMG, ECG, EDA” electrode connection box 3, a connector 4for a microphone, a connenctor 5 for a catheter for measuring rectalpressure, a connector 6 for a catheter for measuring bladder pressure,and a connector 7 for a temperature sensor.

Listing of reference numerals used in the drawing figures and elementsof the apparatus of the present invention denoted thereby:

-   1. Coughing (microphone)-   2. Pulse (ear clip or 2 electrodes)-   3. Marker (2 buttons)-   4. Movement-   5. Pulse, oxygen saturation (finger clip)-   6. Signal preparation, digital port-   7. Serial interface-   8. Memory, SRAM up to 16 MBytes-   9. Serial interface-   10. Memory, 256 MB memory card-   11. RS-232 cable-   12. Reader-   13. Body position-   14. Temperature-   15. Skin measurement (2 electrodes)-   16. EMG-   17. Bladder pressure 1 (catheter)-   18. Rectal pressure (catheter)-   19. Moisture (sensor)-   20. Free access e.g. leg position (thigh—thorax) or flow meter-   21. LED and beeper-   22. Signal preparation, 10 Bit ADC-   23. Real time clock-   24. Battery or accumulator, 2×AAA-   25. RS232 transmission (optical separation) by radio, bluetooth

1-63. (Canceled).
 64. Apparatus for providing data for facilitatingdiagnosis of impairments to bladder function in a human by enablingmeasurement of parameters associated with bladder function, saidapparatus comprising at least one somatic function measuring means formeasuring a somatic function of a human, said somatic function measuringmeans selected from the group consisting of: pulse measuring means;blood pressure measuring means; galvanic skin resistance measuringmeans; core body temperature measuring means; and skin temperaturemeasuring means.
 65. Apparatus according to claim 64, wherein when saidat least one somatic function measuring means is pulse measuring means,said pulse measuring means comprises at least one electrode cable and atleast one pulse measuring clip selected from the group consisting ofear-attachable pulse measuring clips; finger-attachable pulse measuringclips; and, where there is a plurality of said pulse measuring clips,combinations thereof.
 66. Apparatus according to claim 64, wherein whensaid at least one somatic function measuring means is blood pressuremeasuring means, said blood pressure measuring means is non-invasive.67. Apparatus according to claim 64, wherein when said at least onesomatic function measuring means is galvanic skin resistance measuringmeans, said galvanic skin resistance measuring means comprises: anelectrical voltage measuring apparatus that measures an electricalvoltage from an applied electrical voltage source at at least two siteson a skin surface; at least one electrode cable; and a plurality ofelectrodes.
 68. Apparatus according to claim 64, wherein when said atleast one somatic function measuring means is core body temperaturemeasuring means, said core body temperature measuring means comprisesone of: a rectally insertable temperature sensor for measuring core bodytemperature; and an orally ingestible temperature sensor for measuringcore body temperature with an electronic signal transmitter fortransmitting an electronic signal representative of core bodytemperature measured by said temperature sensor, to an externalelectronic signal receiver.
 69. Apparatus according to claim 64, whereinwhen said at least one somatic function measuring means is skintemperature measuring means, said skin temperature measuring meanscomprises a skin surface contacting temperature sensor.
 70. Apparatusaccording to claim 64, further comprising at least one non-somaticfunction measuring means for measuring a non-somatic function of ahuman, said non-somatic function measuring means selected from the groupconsisting of: bladder pressure measuring means; rectal pressuremeasuring means; urethral pressure measuring means; anal sphincterpressure measuring means; incontinenance event occurrence measuringmeans; and incontinence event severity measuring means.
 71. Apparatusaccording to claim 70, wherein when said at least one non-somaticfunction measuring means is bladder pressure measuring means, saidbladder pressure measuring means comprises a catheter having a pressuresensor thereon for measuring bladder pressure.
 72. Apparatus accordingto claim 71, wherein said pressure sensor is on a distal end of saidcatheter, such that when said catheter is trans urethrally inserted intoa bladder, said sensor measures said bladder pressure; and said bladderpressure measuring means further comprises an electronic signaltransmitter for transmitting an electronic signal representative of saidmeasured bladder pressure.
 73. Apparatus according to claim 71, whereinsaid pressure sensor is at a proximal end of said catheter, on anexternal, non-urethrally insertable part thereof, and said bladderpressure measuring means further comprises a pressuredetector/transmitter on a distal end of said catheter, such that whensaid catheter is transurethrally inserted into a bladder, said pressuredetector/transmitter detects bladder pressure and transmits said bladderpressure through said catheter to said pressure sensor.
 74. Apparatusaccording to claim 70, wherein when said at least one non-somaticfunction measuring means is rectal pressure measuring means, said rectalpressure measuring means comprises a catheter having a pressure sensorthereon for measuring rectal pressure.
 75. Apparatus according to claim74, wherein said pressure sensor is on a distal end of said catheter,such that when said catheter is rectally inserted, said sensor measuressaid rectal pressure; and said rectal pressure measuring means furthercomprises an electronic signal transmitter for transmitting anelectronic signal representative of said measured rectal pressure. 76.Apparatus according to claim 74, wherein said pressure sensor is at aproximal end of said catheter, on an external, non-rectally insertablepart thereof, and said rectal pressure measuring means further comprisesa pressure detector/transmitter on a distal end of said catheter, suchthat when said catheter is rectally inserted, said pressuredetector/transmitter detects rectal pressure and transmits said rectalpressure through said catheter to said pressure sensor.
 77. Apparatusaccording to claim 70, wherein when said at least one non-somaticfunction measuring means is urethral pressure measuring means, saidurethral pressure measuring means comprises a catheter having a pressuresensor thereon for measuring urethral pressure.
 78. Apparatus accordingto claim 77, wherein said pressure sensor is on a distal end of saidcatheter, such that when said catheter is urethrally inserted, saidsensor measures said urethral pressure; and said urethral pressuremeasuring means further comprises an electronic signal transmitter fortransmitting an electronic signal representative of said measuredurethral pressure.
 79. Apparatus according to claim 77, wherein saidpressure sensor is at a proximal end of said catheter, on an external,non-urethrally insertable part thereof, and said urethral pressuremeasuring means further comprises a pressure detector/transmitter on adistal end of said catheter, such that when said catheter is urethrallyinserted, said pressure detector/transmitter detects urethral pressureand transmits said urethral pressure through said catheter to saidpressure sensor.
 80. Apparatus according to claim 70, wherein when saidat least one non-somatic function measuring means is anal sphincterpressure measuring means, said anal sphincter pressure measuring meanscomprises a catheter having a pressure sensor thereon for measuring analsphincter pressure.
 81. Apparatus according to claim 80, wherein saidpressure sensor is on a distal end of said catheter, such that when saidcatheter is rectally inserted up to an anal sphincter, said sensormeasures said anal sphincter pressure; and said anal sphincter pressuremeasuring means further comprises an electronic signal transmitter fortransmitting an electronic signal representative of said measured analsphincter pressure.
 82. Apparatus according to claim 80, wherein saidpressure sensor is at a proximal end of said catheter, on an external,non-rectally insertable part thereof, and said anal sphincter pressuremeasuring means further comprises a pressure detector/transmitter on adistal end of said catheter, such that when said catheter is rectallyinserted up to an anal sphincter, said pressure detector/transmitterdetects anal sphincter pressure and transmits said anal sphincterpressure through said catheter to said pressure sensor.
 83. Apparatusaccording to claim 70, comprising bladder pressure measuring means andurethral pressure measuring means; and comprising a single dual lumencatheter having at least one pressure sensor thereon for measuringbladder pressure and for measuring urethral pressure.
 84. Apparatusaccording to claim 70, comprising rectal pressure measuring means andanal sphincter pressure measuring means; and comprising a singlecatheter having at least one pressure sensor thereon for measuringrectal pressure and for measuring anal sphincter pressure.
 85. Apparatusaccording to claim 70, wherein when said at least one non-somaticfunction measuring means is incontinenance event occurrence measuringmeans, said incontinenance event occurrence measuring means comprises amoisture sensor.
 86. Apparatus according to claim 85, wherein saidmoisture sensor utilizes at least one of resistance measurement andcapacity measurement; and said moisture sensor is integrated into adiaper.
 87. Apparatus according to claim 70, wherein when said at leastone non-somatic function measuring means is incontinenance eventoccurrence measuring means, said incontinenance event occurrencemeasuring means comprises a flowmeter that is alternatively externallyand internally patient-borne.
 88. Apparatus according to claim 87,wherein said flowmeter is on a catheter.
 89. Apparatus according toclaim 70, wherein when said at least one non-somatic function measuringmeans is incontinenance event severity measuring means, saidincontinenance event severity measuring means comprises a diaper and amoisture sensor.
 90. Apparatus according to claim 70, comprising bladderpressure measuring means and incontinenance measuring means; andcomprising a single catheter having a pressure sensor thereon formeasuring rectal pressure and for bearing a flowmeter for measuringincontinenance.
 91. Apparatus according to claim 70, further comprisingbody position measuring means for measuring a position of a body of apatient.
 92. Apparatus according to claim 91, wherein said body positionmeasuring means comprises a hollow outer sphere and an inner sphere,rotatably borne within said hollow outer sphere, said inner spherehaving at least one of: a surface segment thereof removed; and a centerof gravity different from a geometric center of said inner sphere, suchthat said inner sphere maintains a constant angle relative to agravitational direction.
 93. Apparatus according to claim 92, whereinsaid inner sphere of said body position measuring means has electricalcontact surfaces on an external surface thereof; and said outer sphereof said body position measuring means has electrical contact surfaces onan internal surface thereof, such that a position of a body isdeterminable when said electrical contact surfaces on said internalsurface of said outer sphere are in electrical contact with saidelectrical contact surfaces on said external surface of said innersphere.
 94. Apparatus according to claim 91, further comprising bodymovement measuring means for measuring movement of a body of a patient.95. Apparatus according to claim 94, wherein said body movementmeasuring means comprises a shock sensor attachable to a body of apatient.
 96. Apparatus according to claim 94, further comprising bodyangle measuring means for measuring a body angle between an upper bodyand a lower extremity, selected from the group consisting of: a thigh;and a leg, of said patient.
 97. Apparatus according to claim 96, whereinsaid body angle measuring means comprises at least one light guide,longitudinally attachable to said lower extremity of said patient, foremitting light energy; a light source for providing light energy to eachof said at least one light guide; a light sensor, for detecting lightenergy emitted by each of said at least one light guide, and forproducing a signal representative thereof; and calculation means forcalculating said body angle from said signal produced by said lightsensor.
 98. Apparatus according to claim 97, wherein each of said atleast one light guide comprises a fiber optic cable.
 99. Apparatusaccording to claim 96, further comprising cough detection means fordetecting and registering the occurrence of a cough reflex in saidpatient.
 100. Apparatus according to claim 99, wherein said coughdetection means comprises acoustic detection means for detectingacoustic signals.
 101. Apparatus according to claim 100, wherein saidacoustic detection means is a microphone.
 102. Apparatus according toclaim 99, wherein said cough detection means comprises a longitudinallyelastically extensible thoracic band for close contacting placementaround a thorax of a patient; and a sensor for measuring a change inlength of said thoracic band upon occurrence of a cough reflex in saidpatient.
 103. Apparatus according to claim 100, further comprising amicroprocessor for analyzing said acoustic signals detected by saidacoustic detection means for determining the occurrence of a coughreflex in said patient.
 104. Apparatus according to claim 96, furthercomprising muscle tension measuring means for measuring muscle tensionin at least one muscle selected from the group consisting of: abdominalmusculature; and urethral sphincter muscle; said muscle tensionmeasuring means comprising a plurality of electrodes for measuringvoltage produced by said muscle.
 105. Apparatus according to claim 104,further comprising bladder fullness measuring means for measuring avolume of fluid in a bladder of a patient.
 106. Apparatus according toclaim 105, further comprising data recording and storing means forrecording and storing data obtained by any of said measuring means andsaid detection means.
 107. Apparatus according to claim 106, whereinsaid data recording and storing means stores data for a predeterminedperiod of time.
 108. Apparatus according to claim 106, wherein said datarecording and storing means comprises at least one of: magnetic medium;optical medium; analog medium; digital medium; and combinations thereof.109. Apparatus according to claim 108, wherein when said recording andstoring means is a digital medium, said digital medium comprises aplurality of digital integrated circuit memory chips.
 110. Apparatusaccording to claim 106, wherein said recording and storing means iserasable and rewriteable.
 111. Apparatus according to claim 106, whereinsaid recording and storing means has sufficient capacity to record andstore data for at least two hours.
 112. Apparatus according to claim111, wherein said recording and storing means has sufficient capacity torecord and store data for greater than two hours.
 113. Apparatusaccording to claim 112, wherein said recording and storing means hassufficient capacity to record and store data for six hours. 114.Apparatus according to claim 112, wherein said recording and storingmeans has sufficient capacity to record and store data for 24 hours.115. Apparatus according to claim 106, further comprising marker meansfor enabling patient-actuated manual entry of data into said recordingand storing means.
 116. Apparatus according to claim 115, wherein saiddata to be manually entered is data relating to occurrence ofpatient-subjectively-experienced events relating to bladder function.117. Apparatus according to claim 115, wherein said marker means isalternatively one or a plurality of user-actuated devices. 118.Apparatrus according to claim 117, wherein said user-actuated devicesare selected from the group consisting of: buttons, switches, knobs,and, where there is a plurality of said user-actuated devices,combinations thereof.
 119. Apparatus according to claim 117, whereinwhen there is one user-actuated device, said device is multifunctionaland capable of separately marking occurrence of a plurality of differentevents of a predetermined nature.
 120. Apparatus according to claim 117,wherein when there is a plurality of user-actuated devices, each of saiddevices is dedicated to marking single or repetitive occurrence of anevent of a predetermined nature.
 121. Apparatus according to claim 117,wherein said marker means is capable of determining a relative intensityof each occurrence of said patient-subjectively-experienced eventrelating to bladder function triggering user actuation of said markermeans.
 122. Apparatus according to claim 121, wherein relative intensityof each said occurrence of said patient-subjectively-experienced eventrelating to bladder function is expressed through a characteristicparameter of said marker means.
 123. Apparatus according to claim 122,wherein said marker means is a variable rheostat and characteristicparameter is electrical resistance.
 124. Apparatus according to claim121, wherein a parameter of an output signal of said marker means isproportional to a relative intensity of saidpatient-subjectively-experienced event relating to bladder function.125. Apparatus according to claim 124, wherein: when said marker meansincludes a button, relative intensity of saidpatient-subjectively-experienced event relating to bladder function isexpressed by one of proportionality of a user-applied force to saidbutton and frequency of repetitive actuation of said button; when saidmarker means includes a switch, relative intensity of saidpatient-subjectively-experienced event relating to bladder function isexpressed by one of selection of a position of a more than bipositionalmultipositional switch and by frequency of repetitive actuation of saidswitch; and when said marker means includes a rotatable knob, relativeintensity of said patient-subjectively-experienced event relating tobladder function is expressed by selection of a position of said knobcoordinated to indicia of intensity.
 126. Apparatus according to claim116, wherein said patient-subjectively-experienced event relating tobladder function is selected from the group consisting of: consumptionof liquid by said patient; sensation of an urge to urinate; andurination.
 127. Apparatus according to claim 115, further comprisingvideo image recording means for recording patient image data. 128.Apparatus according to claim 127, wherein said video image recordingmeans comprises one selected from the group consisting of a video cameraand a digital camera.
 129. Apparatus according to claim 127, whereinsaid video image recording means is used to record patient image data,while said patient is sleeping.
 130. Apparatus according to claim 129,wherein said patient image data recorded while said patient is sleepingis used to determine occurrence of events symptomatic of impairedbladder function in said patient.
 131. Apparatus according to claim 128,wherein said video image recording means is capable of recording patientimage data for a period of up to 12 hours.
 132. Apparatus according toclaim 128, wherein when said video image recording means is a digitalcamera, said digital camera further comprises digital storage means forstoring digital image data recorded by said digital camera for a periodof up to 12 hours.
 133. Apparatus according to claim 132, wherein saiddigital storage means comprises at least one digital memory card. 134.Apparatus according to claim 127, further comprising a transmitter fortransmitting data representative of measured values obtained by at leastsome of said measuring means and said detection means.
 135. Apparatusaccording to claim 134, wherein said transmitter is electronic and saiddata is transmitted electronically.
 136. Apparatus according to claim134, further comprising a receiver for receiving data transmitted bysaid transmitter.
 137. Apparatus according to claim 136, wherein saidreceiver is electronic and said data is transmitted by said transmitterand received by said receiver electronically.
 138. Apparatus accordingto claim 137, wherein said data is electronically transmitted andreceived by one selected from the group consisting of: radio waves; andlight waves.
 139. Apparatus according to claim 138, wherein said data iselectronically transmitted and received by radio waves.
 140. Apparatusaccording to claim 140, wherein said radio waves are short range radiowaves.
 141. Apparatus according to claim 137, wherein electronic datatransmission and reception is wireless.
 142. Apparatus according toclaim 137, wherein at least one of electronic data transmission by saidtransmitter; electronic data reception by said receiver; and electroniccommunication between said transmitter and said receiver, occursautomatically.
 143. Apparatus according to claim 136, wherein said datarecording and storing means and said receiver are proximally located.144. Apparatus according to claim 136, wherein said data recording andstoring means is housed in a portable module.
 145. Apparatus accordingto claim 144, wherein said portable module is patient-wearable. 146.Apparatus according to claim 144, wherein all of said measuring meansand said detection means are in electronic communication with saidmodule.
 147. Apparatus according to claim 146, wherein said module isbattery powered.